BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Premium Implant Systems - Shelta Implant Systems

    Reg #: 3011276344 · FEI: 3011276344 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    SWEDEN & MARTINA INC
    Registration Number
    3011276344
    FEI Number
    3011276344
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    916 SPINDLETREE AVENUE
    City
    Naperville
    State
    IL
    ZIP
    60565
    Country
    US

    Regulatory Submissions

    510(k) Number
    K142242

    Owner / Operator

    Firm Name
    Sweden & Martina INC
    Operator Number
    10048147
    Address
    916 SPINDLETREE AVENUE
    City
    Naperville
    State
    IL
    Postal Code
    60565
    Country
    US
    Correspondent
    Alessia Pezzato

    Products

    Device Name Product Code
    Implant, Endosseous, Root-Form DZE
    Abutment, Implant, Dental, Endosseous NHA

    Proprietary Names

    Premium Implant Systems - Shelta Implant Systems

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198